FREE Study: Efficacy and Toxicity of Trizivir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00405925
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : June 2, 2010
Information provided by:
Rijnstate Hospital

Brief Summary:
Antiretroviral naïve patients with <350 xE6/l CD4 cells and a HIV-viral load of > 30.000 cop/ml are started on combivir ® and Kaletra ®. When patients have reached an undetectable viral load of< 50 cop/ml on two consecutive occasions at least at week 12, but no later than week 24, they are randomised in either continuation with Combivir/Kaletra or switch to Trizivir ® twice daily one pill during 96 weeks. All patients randomised in the combivir/Kaletra arm are eligible to switch to Trizivir at any post randomisation visit when they reach predefined switch criteria for elevated levels of fasting glucose or lipids.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Trizivir Drug: zidovudine,lamivudine,abacavir Phase 3

Detailed Description:
The primary objective is to compare the antiviral efficacy of an early switch from a boosted PI/2NRTI regimen to Trizivir (after undetectability of HIV-RNA has been achieved on 2 consecutive occasions) with uninterrupted use of the PI/2NRTI regimen for 96 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Free Study: a Randomised, Open Label, Multicentre Strategic Study to Evaluate the Efficacy and Toxicity of an Early Switch From a PI-containing Regimen to Trizivir ® on Guidance of Viral Load in HIV-1 Infected , Antiretroviral naïve Adults
Study Start Date : March 2003
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: combivir/kaletra
All patients started with combivir/Kaletra and were randomized if they reached undetectable viral load (2 times) within 24 weeks into continuation of the same regimen or Trizivir (2 arms)
Drug: zidovudine,lamivudine,abacavir
zidovudine 300 mg bid, lamivudine 150mg bid, abacavir 300mg bid

Experimental: Trizivir
patients who reach undetectable HIV-RNA within 24 weeks are randomized to switch to trizivir or continuation of combivir/kaletra
Drug: Trizivir

Primary Outcome Measures :
  1. Plasma HIV-RNA < 400 cop/ml at week 96 for the Intent- To-Treat (ITT).

Secondary Outcome Measures :
  1. HIV-RNA <50 cop at week 96
  2. HIV-RNA <400 and <50 cop/ml at week 48
  3. Time to virological failure
  4. Immunological efficacy at week 48 and 96 measured by absolute change from baseline in CD4 cell counts
  5. Duration of change in CD4 cell count from baseline to >200,
  6. Proportion of subjects experiencing one or more predefined values of fasting glucose and triglycerides, LDL and LDL/HDL ratio
  7. Development of adverse events

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults >18 years of age, confirmed HIV-1 infection, never received antiretrovirals before, plasma-HIV-RNA >30.000 cop/ml, CD4 < 350 E6/l.

Exclusion Criteria:

  • pregnancy, women using proven barrier methods of contraception, defined uncontrolled active AIDS defining complication, being on treatment for diabetes, other serious illnesses, expected non-compliance, defined laboratory abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00405925

Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA
Sponsors and Collaborators
Rijnstate Hospital
Principal Investigator: Clemens Richter, MD Rijnstate Hospital, Arnhem, the Netherlands
Study Director: P. Mulder Rijnstate Hospital, Arnhem, the Netherlands
Study Director: N. Langebeek Rijnstate Hospital, Arnhem, the Netherlands
Study Director: D. N. Burger Nijmegen, the Netherlands
Study Director: P. P. Koopmans Nijmegen, the Netherlands
Study Director: C. H. ten Napel Enschede, the Netherlands
Study Director: P. H. Groeneveld Isala kliniek, Zwolle, the Netherlands
Study Director: H. G. Sprenger Groningen, the Netherlands
Study Director: R. W. ten Kate Haarlem, the Netherlands
Study Director: M. E. van Kasteren Tilburg, the Netherlands
Study Director: J. D. Le grand Charleroi, Belgium
Study Director: R. Vriesendorp The Hague, the Netherlands
Study Director: B. Bravenboer Eindhoven, the Netherlands
Study Director: I. M. Hoepelman Utrecht, the Netherlands
Study Director: P. van Bentum Rijnstate Hospital, Arnhem, the Netherlands
Study Director: A. Smit-den Baars Rijnstate Hospital, Arnhem, the Netherlands Identifier: NCT00405925     History of Changes
Other Study ID Numbers: LTC-184-010403
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: June 2, 2010
Last Verified: May 2010

Keywords provided by Rijnstate Hospital:
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine, zidovudine drug combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents